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Lexapro (Escitalopram Oxalate) - Summary

 
 



WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients less than 12 years of age. [See Warnings and Precautions: Clinical Worsening and Suicide Risk Patient Counseling Information: Information for Patients (17.1), and Used in Specific Populations: Pediatric Use].

 

LEXAPRO SUMMARY

LEXAPRO® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.

LEXAPRO (escitalopram) is indicated for the following:

MAJOR DEPRESSIVE DISORDER

LEXAPRO (escitalopram) is indicated for the treatment of major depressive disorder.

The efficacy of LEXAPRO in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of LEXAPRO in hospitalized patients with major depressive disorders has not been adequately studied.

The efficacy of LEXAPRO in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking LEXAPRO and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

GENERALIZED ANXIETY DISORDER

LEXAPRO is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of LEXAPRO was established in three, 8-week, placebo-controlled trials in patients with GAD (see CLINICAL PHARMACOLOGY).

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

The efficacy of LEXAPRO in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


See all Lexapro indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Lexapro (Escitalopram)

A double-blind, randomized, placebo-controlled clinical trial of S-adenosyl-L-methionine (SAMe) versus escitalopram in major depressive disorder. [2014]
CONCLUSIONS: The results fail to support an advantage over placebo for either the

Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. [2012]
The primary objective of this study was to examine the short-term effects of escitalopram on symptoms of night eating syndrome (NES) in a randomized controlled clinical trial. A total of 40 patients with NES were randomly assigned to double-blind treatment with escitalopram 20 mg (n = 20) or placebo (n = 20) for 12 weeks...

Effect of escitalopram on hot flash interference: a randomized, controlled trial. [2012]
OBJECTIVE: To estimate the effect of escitalopram (10-20 mg/d) versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life... CONCLUSION(S): Escitalopram (10-20 mg/d) for 8 weeks improves women's quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables.

No evidence for an anti-inflammatory effect of escitalopram intervention in healthy individuals with a family history of depression. [2012]
Inflammation may contribute to the pathogenesis of depression and antidepressants are hypothesised to have an anti-inflammatory effect. In this randomised double-blinded trial we investigated the cytokine levels in supernatants of stimulated whole blood samples from first degree relatives to patients with depression randomised to a single daily dose of either 10mg escitalopram or placebo for four weeks.

A review of escitalopram and citalopram in child and adolescent depression. [2011.11]
OBJECTIVE: To review the basic pharmacology and published literature regarding escitalopram and citalopram in child and adolescent depression... CONCLUSION: At present, escitalopram and citalopram should be considered a second-line option for adolescent depression. The US Food and Drug Administration approval of escitalopram for treatment of adolescent depression was based on a single positive RCT. This is less evidence than typically required for approval of a drug for a new indication.

more studies >>

Clinical Trials Related to Lexapro (Escitalopram)

Escitalopram (LexaproŽ) In Patients With Major Depression With Atypical Features [Completed]
Aims of Study:

The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features.

Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.

Brain Effects of Escitalopram and Citalopram Using fMRI [Recruiting]
Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating mood. Escitalopram consists of S-citalopram while citalopram contains both S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may block the effects of S-citalopram. The hypothesis being tested is that because of the antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood circuit than racemic citalopram when equal doses of S-citalopram are administered.

Food Study of Escitalopram Oxalate Tablets 20 mg to LexaproŽ Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's LexaproŽ 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fed conditions.

Fasting Study of Escitalopram Oxalate Tablets 20 mg and LexaproŽ Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's LexaproŽ 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fasting conditions.

Responses of Myocardial Ischemia to Escitalopram Treatment [Recruiting]
Depression is commonly seen in patients with cardiovascular disorders. In recent studies it has been shown that mild to moderate depression symptoms were associated with increased likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of poor cardiac outcome. In this project, the investigators aim to assess the treatment of mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to moderate depressive symptoms. This study is a six-week double-blind placebo controlled study to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This study will look to show that patients with ischemic heart disease who are treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo.

more trials >>

Reports of Suspected Lexapro (Escitalopram) Side Effects

Drug Ineffective (61)Suicidal Ideation (57)Depression (56)Nausea (56)Anxiety (49)Insomnia (47)Maternal Drugs Affecting Foetus (39)Weight Increased (38)Headache (37)Feeling Abnormal (35)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 74 ratings/reviews, Lexapro has an overall score of 6.89. The effectiveness score is 7.46 and the side effect score is 7.30. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Lexapro review by 36 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression/anxiety
Dosage & duration:   10mg daily taken daily for the period of two months and continuingto use it
Other conditions:   frustrated/short temper/mood swings
Other drugs taken:   none
  
Reported Results
Benefits:   better outlook on life in general, less anxious, easier to deal with everything, a difference of night and day
Side effects:   during the initial dose(first week to ten days) a bit of nausea,strange sensation in teeth and my head felt a little odd
Comments:   I am happily married with two children, ages three and five. For years I cried everyday, freaked out at the drop of a hat, yelled all the time, had no self esteem and sometimes thought I could not go on. After two weeks of taking Lexapro I am a completely different person. I have not cried once after the first week of being treated. I love myself and my kids. All the menial tasks that I felt so difficult before, I now do with a great sense of ease. My friends and family notice a huge change in me. I couldn't be happier.

 

Lexapro review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   anxiety and depression
Dosage & duration:   10mg taken daily for the period of 2 years
Other conditions:   going through menopause
Other drugs taken:   none
  
Reported Results
Benefits:   After the first few DAYS my anxiety was greatly reduced. I felt less depressed and did not feel prone to panic attacks that I had been having prior to starting this medication. I was very pleased with the reduced anxiety and depression.
Side effects:   At first I had some mild nausea, which went away and then I didn't have any side effects. This medication did not make me gain weight and it did not lower my sex drive- both which were concerns for me.
Comments:   The medication worked great, and I would have rated it a 10 except getting OFF the medication was difficult. For six-eight weeks I had what I've come to learn are called brain zaps... a strange sensation that is difficult to describe and not pleasant. Lucky for me I had read about this so it did not scare me... otherwise I would have been very concerned. I pretty much just rode it out for those 6-8 weeks and then it went away and I've been fine. If I had to do it over I would still have chosen to take the lexapro because is was so effective for my anxiey/depression which was off the charts when I started.

 

Lexapro review by 29 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   10mg taken once a month for the period of 2 days
Other conditions:   biploar
Other drugs taken:   lithum
  
Reported Results
Benefits:   It was suspose to help ease my depression issues that happend when the biploar side of me was not in hyper. It was a new drug it was suspose to be very effeect. Not cause any weight gain. With very little side effects.
Side effects:   I had very bads nightmares for about two nights. The nightmare wre of me hurting my family. I could see myself killing my family it seemed so very real to me I have never experienced any thing like that before in my life. I told my husband to stay up and please watch me to make sure do not do any thing.So I did not take them any more
Comments:   I was to take one 10mg pill at night before I go to bed every night. It did not matter if it was taken with food or with out food. Either way was fine. I had to take it at the same time every night. I was not suspose ot stop treatment unless my doctor said it was ok.

See all Lexapro reviews / ratings >>

Page last updated: 2014-11-30

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